Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Last updated: January 7, 2022
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT03548987
NN9536-4376
2017-003473-34
U1111-1201-0898
  • Ages > 18
  • All Genders

Study Summary

This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.

The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age greater than or equal to 18 years at the time of signing informedconsent
  • Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27kg/sqm with the presence of at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea orcardiovascular disease
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion

Exclusion Criteria:

  • Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by centrallaboratory at screening
  • A self-reported change in body weight more than 5 kg (11 lbs) within 90 days beforescreening irrespective of medical records

Study Design

Total Participants: 902
Study Start date:
June 04, 2018
Estimated Completion Date:
March 20, 2020

Connect with a study center

  • Novo Nordisk Investigational Site

    Frederiksberg C, 1958
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Køge, 4600
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Haifa, 35152
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Jerusalem, 91120
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah-Tikva, 49372
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Amsterdam, 1066 EC
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Braga, 4710-243
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Coimbra, 3000-561
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Matosinhos, 4464-513
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Porto, 4099-001
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Vila Nova de Gaia, 4400-346
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng 0184
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4001
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Brits, North West 0250
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Almeria, 04009
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Almería, 04001
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Madrid, 28009
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Sabadell, 08208
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Malmö, 205 02
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Stockholm, 141 86
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Genève 14, 1211
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Olten, 4600
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Zollikerberg, 8125
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Zürich, 8091
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kyiv, 03039
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Odesa, 65059
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fresno, California 93720
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92108
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Elkridge, Maryland 21075-6437
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68198-3020
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10016
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dayton, Ohio 45406
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, Tennessee 37620-7352
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75226
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wenatchee, Washington 98801-2028
    United States

    Site Not Available

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